NOVEN'S ESTRADOT RECEIVES FIRST EUROPEAN MARKETING AUTHORIZATION

World's Smallest Transdermal Hormone Replacement Therapy
Approved in the Netherlands
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MIAMI, FL. - March 22, 2001 - Noven Pharmaceuticals, Inc. (Nasdaq:NOVN), today announced that regulatory authorities in the Netherlands have approved Estradot® (transdermal 17-beta estradiol) for the treatment of menopausal symptoms and for the prevention of post menopausal osteoporosis. The Netherlands will act as the Reference Member State as Novartis, the product's licensee, will seek pan-European approval for Estradot® under the EC Mutual Recognition Procedure.

Estradot®, developed and manufactured by Noven, is a state-of-the-art estrogen patch. At one-third the size of competing products, it is the smallest estrogen patch in the world and offers patients a convenient, comfortable and cosmetically attractive means of administering hormone replacement therapy.

Novartis has licensed Estradot® from Noven in all countries outside of the U.S. and Japan. Novartis and Noven already jointly market the product as Vivelle-Dot™ in the U.S. through their jointly-owned Women's Health company, Vivelle Ventures LLC (also known as Novogyne Pharmaceuticals).

Robert C. Strauss, Noven's President, Chief Executive Officer and Co-Chairman, said: "We are pleased that the first European approval for Estradot® is in hand and that the Mutual Recognition Procedure can now begin. Novartis' significant global resources and demonstrated commitment to Women's Health give us great confidence in its ability to successfully commercialize Estradot® in the licensed territories."

About Noven
 Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leader in the development of transdermal and transmucosal drug delivery technologies and products. Together with Novartis Pharmaceuticals, Noven owns a women's health products company called Novogyne Pharmaceuticals. Noven's existing products include advanced estrogen transdermal delivery systems (including Vivelle® and Vivelle-Dot™, licensed to Novogyne, and Estradot®, licensed to Novartis) and combination estrogen/progestin transdermal delivery systems (including CombiPatch™, licensed to Aventis, and Estalis®, licensed to Novartis). With a range of additional products in development, including once-daily MethyPatch® for Attention Deficit Hyperactivity Disorder, Noven is committed to becoming the world's premier developer, manufacturer and marketer of transdermal and transmucosal drug delivery systems.

For additional information on Noven, visit the company's web site at www.noven.com. For information on Noven's Vivelle® and Vivelle-Dot™ products, visit www.vivelledot.com.

This release contains forward looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These statements can be identified by, among other things, terminology such as "will seek", "expected", "aspirations", "estimated" or similar expressions. Many factors may cause the actual results, performance or achievements to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Some of these are uncertainties relating to product development, unexpected regulatory delays, government regulation generally, the ability to successfully commercialize the product, or the ability to obtain or maintain patent or other proprietary intellectual property protection, as well as factors discussed in the Form 10-K and Form 10-Qs filed by Noven with the Securities and Exchange Commission. Any of these or other factors can cause the actual results to vary materially from those described herein.

Investor & Media Contact:
Joseph C. Jones
Vice President, Corporate Affairs
Noven Pharmaceuticals, Inc.
(305) 253-1916

 

 

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